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Alinity i B12 Reagent Kit - India CDSCO Medical Device Registration

Alinity i B12 Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000223_ff47f3fc0fe1d1f3bba0dd2cd14981f8_bd980c386e9a686b36fb96ff9d9fd1c8. This device is marketed under the brand name ARCHTECT Total T4 Controls. The license holder is Abbott Healthcare Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Alinity i B12 Reagent Kit
UID: IMP/MD/2018/000223_ff47f3fc0fe1d1f3bba0dd2cd14981f8_bd980c386e9a686b36fb96ff9d9fd1c8

Brand Name

ARCHTECT Total T4 Controls

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Alinity i B12 assay is a chemiluminescent microparticle Intrinsic Factor assay used for the quantitative determination of vitamin B12 in human serum and plasma on the Alinity i analyzer

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